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Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity of Residual Post-surgical Neuropathic Pain After a Surgery for Disc Herniation

NCT05196503

RecruitingPhase 3

Sponsor: University Hospital, Strasbourg, France

Conditions: Neuropathic Pain, Chronic Postsurgical Pain

Interventions: Treatment

Countries: France

The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* Patient, male or female, \>18 years old at the time of signing informed consent;
* Patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the Neurosurgery department;
* Patient affiliated to a social security health insurance scheme;
* Patient able to understand the objectives and risks of research and to give informed, dated and signed consent;
* Patient having been informed of the results of the prior medical examination;
* Women of childbearing age provided that a negative blood pregnancy test is recorded at the inclusion visit and effective contraception used throughout the study.

Exclusion criteria:

* Patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar);
* Patient with HIV, active cancer, HBV, HCV (verified by interview);
* Patient on long-term systemic corticosteroid therapy;
* Patient with an ASA score \> 3 during the consultation with the anesthesiologist;
* Inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding);
* Patient in exclusion period (determined by a previous or ongoing study);
* Subject under safeguard of justice;
* Subject under curatorship;
* Pregnancy;
* Breastfeeding.

Locations (1)

Strasbourg, Bas-Rhin, France